The following data is part of a premarket notification filed by Eclipse Medcorp Llc with the FDA for Eclipse Blood Collection Set.
| Device ID | K213690 |
| 510k Number | K213690 |
| Device Name: | Eclipse Blood Collection Set |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Eclipse Medcorp LLC 5916 Stone Creek Drive Suite #120 The Colony, TX 75056 |
| Contact | Julie Summerville |
| Correspondent | Julie Summerville Eclipse Medcorp LLC 5916 Stone Creek Drive Suite #120 The Colony, TX 75056 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-23 |
| Decision Date | 2022-10-26 |